King of Prussia, Pennsylvania – Trice Medical officials announced that the company has received 510(k) regulatory clearance from the United States Food and Drug Administration (FDA) for its new device, mi-eye.
mi-eye is designed to provide a more immediate, definitive and less expensive diagnosis, eliminating the false reads of indirect modalities, such as MRIs. mi-eye is a fully disposable, single-use, streamlined visualization device that uses a standard 14-gauge needle with an integrated camera and light source to perform a diagnostic arthroscopy – all while in the physician’s office during the initial consultation. A separate LCD tablet, running on Android OS, is attached via a data cable from the mi-eye needle. mi-eye is delivered to customers in sterile packaging and ready for immediate use.
Jeff O’Donnell, chairman and CEO of Trice Medical, commented, “The FDA clearance of mi-eye is a key milestone in Trice Medical’s pursuit of needle based diagnostic and therapeutic technologies. The company will also apply for CE Mark in Europe and approval in many countries outside the U.S.”
Source: Trice Medical